A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on Adagrasib

Healthy Adults Clinical Trial

Official title:

A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05924152
• Other study ID #: 849-025
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2023
• Est. completion date: August 17, 2023

Study information

• Verified date: March 2024
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 17, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.

2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.

3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator.

4. Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception.

5. Male subjects must agree to use contraception.

6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.

2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (IP), or other substance (not including seasonal allergies).

3. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome).

4. Significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities.

5. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.

6. Ventricular dysfunction or history of risk factors for Torsades de Pointes.

7. History of drug abuse within 2 years prior to Screening.

8. History of alcohol abuse within 12 months prior to Screening.

9. Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) 1/2.

10. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.

11. Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination.

12. Use or intend to use any prescription medications/products within 14 days prior to Check-in.

13. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations.

14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.

15. Subjects who, in the opinion of the Investigator, should not participate in this study.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• Adagrasib
Adagrasib
• Eltrombopag + adagrasib
Eltrombopag + adagrasib

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Daytona Beach (Labcorp Clinical Research Unit Daytona Beach)	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - AUC (adagrasib)	Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC8)	Days 1 and 8
Primary	Pharmacokinetics - AUC (adagrasib)	AUC from time zero to the last quantifiable concentration (AUClast)	Days 1 and 8
Primary	Pharmacokinetics - Cmax (adagrasib)	Maximum observed plasma concentration (Cmax)	Days 1 and 8
Primary	Pharmacokinetics - Tmax (adagrasib)	Time to reach Cmax (tmax)	Days 1 and 8
Primary	Pharmacokinetics - t1/2 (adagrasib)	Elimination half-life (t1/2)	Days 1 and 8
Primary	Pharmacokinetics - CL/F (adagrasib)	Apparent total plasma clearance (CL/F)	Days 1 and 8
Primary	Pharmacokinetics - Vz/F (adagrasib)	Apparent volume of distribution (Vz/F)	Days 1 and 8
Secondary	Adverse Events (AEs)	Incidence and severity of AEs	Up to 8 weeks from screening